LEGISLATION, OTHER CODES and GUIDELINES
LEGISLATION
The Human Medicines Regulations 2012 as amended
2012 No. 1916
The Human Medicines (Amendment) (No. 2) Regulations
2014 No. 1878
The Consumer Protection from Unfair Trading Regulations 2008
2008 No. 1277
Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC
Bribery Act 2010
Data Protection Act 2018
OTHER CODES
International
IFPMA Code of Practice (International Federation of Pharmaceutical Manufacturers and Associations)
EFPIA Code of Practice (European Federation of Pharmaceutical Industries and Associations)
WHO Ethical Criteria for Medicinal Drug Promotion, Geneva 1988 (World Health Organisation)
IPCAA International Healthcare Congress Guidelines (International Pharmaceutical Congress Advisory Association)
United Kingdom
The UK Code of Non-broadcast Advertising and Direct & Promotional Marketing (Committee of Advertising Practice/Advertising Standards Authority)
Codes of Practice for Advertising Over-the-Counter Medicines – the PAGB Consumer Code and the PAGB Professional Code (Proprietary Association of Great Britain – PAGB)
BMA ‘Medical ethics today’ (British Medical Association)
General Medical Council ‘Ethical guidance for doctors’
General Pharmaceutical Council ‘Standards for pharmacy professionals’
Nursing & Midwifery Council ‘Professional standards of behaviour for nurses, midwives and nursing associates’
NHS England Standards of Business Conduct Policy, 2019
NHS Managing Conflicts of Interest: Revised statutory guidance for CCGs [Clinical Commissioning Groups] 2017
Joint Statement of Chief Executives of statutory regulators of health and care professionals
GUIDELINES
Advertising and Promotion of Medicines in the UK (2020) – The Blue Guide (Medicines and Healthcare products Regulatory Agency). It includes Disease Awareness Campaigns Guidelines and Medicines which are promoted for use during pregnancy – Guidance for the pharmaceutical industry
Best practice guidance on joint working between the NHS and the pharmaceutical industry and other relevant commercial organisations (Department of Health)
Moving beyond sponsorship: interactive toolkit for joint working between the NHS and the pharmaceutical industry (Department of Health/ABPI)
ABPI Guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients, March 2009
Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 2009 (www.ifpma.org/resources/position-papers)
Joint Position on the Publication of Clinical Trial Results in the Scientific Literature 2010 (www.ifpma.org/resources/position-papers)
The Legal & Ethical Guidelines for Healthcare Market Research (British Healthcare Business Intelligence Association/ABPI)
PMCPA GUIDANCE is available at www.pmcpa.org.uk